Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol

BACKGROUND Emotion regulation has been identified as an important transdiagnostic factor relevant to the treatment of mental health disorders. Many empirically validated psychotherapeutic treatments incorporate elements targeting emotion regulation. Most of these treatment approaches are conceptualized as standard face-to-face treatments not as blended treatments, which include an internet-based intervention. OBJECTIVE The aim of this study is to examine, for the first time, a new internet-based intervention—REMOTION—that will be provided transdiagnostically, as an add-on to psychotherapy, to provide a blended treatment format. METHODS A total of 70 participants will be assigned (1:1 allocation ratio) to either the intervention group (REMOTION + psychotherapy) or the treatment-as-usual group that receives psychotherapy alone. To maximize external validity, a typical outpatient treatment sample of patients diagnosed with a range of disorders such as depression, anxiety disorders, and adjustment disorder will be recruited from a university outpatient clinic. Patients with bipolar disorder, psychotic disorders, or acute suicidality will be excluded from the study. The feasibility and potential effectiveness of the intervention will be examined by assessing data at baseline, 6 weeks (post), and 12 weeks (follow-up). The primary outcome is general symptom severity, assessed with the Brief Symptom Inventory. Secondary outcomes are emotion regulation, depressive symptoms, anxiety symptoms, health related quality of life, well-being, and a variety of feasibility parameters. Quantitative data will be analyzed on an intention-to-treat basis. RESULTS Participant recruitment and data collection started in February 2020, and as of November 2020, are ongoing. Results for the study are expected in 2022. CONCLUSIONS This pilot randomized controlled trial will inform future studies using transdiagnostic blended treatment. CLINICALTRIAL ClinicalTrials.gov NCT04262726; http://clinicaltrials.gov/ct2/show/NCT04262726 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20936

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Evaluation of the My Diabetes Care Patient Portal Intervention: Protocol for a Pilot Randomized Controlled Trial (Preprint)

JMIR Research Protocols ◽

10.2196/25955 ◽

2020 ◽

Author(s):

William Martinez ◽

Amber J. Hackstadt ◽

Gerald B. Hickson ◽

S. Trent Rosenbloom ◽

Tom A. Elasy

Keyword(s):

Randomized Controlled Trial ◽

Diabetes Care ◽

Controlled Trial ◽

Care Patient ◽

Patient Portal ◽

Randomized Controlled ◽

Intervention Protocol ◽

Pilot Randomized Controlled Trial

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REMOTION Blended Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting: Protocol for a Pilot Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/20936 ◽

2020 ◽

Vol 9 (11) ◽

pp. e20936

Author(s):

Laura Luisa Bielinski ◽

Tobias Krieger ◽

Franz Moggi ◽

Leonie Trimpop ◽

Ulrike Willutzki ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Emotion Regulation ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Brief Symptom Inventory ◽

Randomized Controlled ◽

Blended Treatment ◽

Internet Based Intervention ◽

Pilot Randomized Controlled Trial

Background Emotion regulation has been identified as an important transdiagnostic factor relevant to the treatment of mental health disorders. Many empirically validated psychotherapeutic treatments incorporate elements targeting emotion regulation. Most of these treatment approaches are conceptualized as standard face-to-face treatments not as blended treatments, which include an internet-based intervention. Objective The aim of this study is to examine, for the first time, a new internet-based intervention—REMOTION—that will be provided transdiagnostically, as an add-on to psychotherapy, to provide a blended treatment format. Methods A total of 70 participants will be assigned (1:1 allocation ratio) to either the intervention group (REMOTION + psychotherapy) or the treatment-as-usual group that receives psychotherapy alone. To maximize external validity, a typical outpatient treatment sample of patients diagnosed with a range of disorders such as depression, anxiety disorders, and adjustment disorder will be recruited from a university outpatient clinic. Patients with bipolar disorder, psychotic disorders, or acute suicidality will be excluded from the study. The feasibility and potential effectiveness of the intervention will be examined by assessing data at baseline, 6 weeks (post), and 12 weeks (follow-up). The primary outcome is general symptom severity, assessed with the Brief Symptom Inventory. Secondary outcomes are emotion regulation, depressive symptoms, anxiety symptoms, health related quality of life, well-being, and a variety of feasibility parameters. Quantitative data will be analyzed on an intention-to-treat basis. Results Participant recruitment and data collection started in February 2020, and as of November 2020, are ongoing. Results for the study are expected in 2022. Conclusions This pilot randomized controlled trial will inform future studies using transdiagnostic blended treatment. Trial Registration ClinicalTrials.gov NCT04262726; http://clinicaltrials.gov/ct2/show/NCT04262726 International Registered Report Identifier (IRRID) DERR1-10.2196/20936

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